1. Field of the Invention
The present invention relates to a composition obtained from plant extracts, and more particularly to the composition comprising a specific ratio of green tea extract to turmeric extract. The present invention also relates to an application of the composition, and more particularly for promoting weight loss and reducing body fat. The present invention also relates to a pharmaceutical composition, and more particularly to the pharmaceutical composition comprising the above-said composition. The present invention also relates to an application of the pharmaceutical composition, and more particularly for promoting weight loss and reducing body fat.
2. Description of the Prior Arts
As defined by the World Health Organization (WHO), the body mass index (BMI) greater than 25 is classified as overweight and BMI greater than 30 as obesity. According to the global statistics in 2014, the population of overweight and obesity is over 2.7 billion, of which approximately 13% population would be obese. These obese people suffer from cardiovascular diseases, hyperlipidemia, diabetes, and cancers at sharply higher probabilities than the average. According to the report of the WHO, among the global leading risks for mortality caused by diseases, overweight and obesity ranked 6th, and at least more than 3.4 million adults die of chronic diseases caused by overweight or obesity in 2013, wherein the medical burden of 44% of diabetes and 23% of ischemic heart disease are attributable to obesity. Studies also showed that the age of obese people is in a gradually downward trend. Approximately 40 million children under age five are overweight worldwide in 2011. According to the report by the Johns Hopkins University Bloomberg School of Public Health published in 2007, approximately 75% and 41% adults would be overweight and obese, respectively, in the USA in 2015. With the rising of developing countries, the population of obesity is rapidly increasing and obesity becomes one of the major epidemics. The Centers for Disease Control and Prevention (CDC) in the USA noted that the population of obese adults in the USA is more than 72 million, and 40% of global obese population is in Asia. The population of overweight and obese adults was increased from 25% to 38.5% in China from 2002 to 2010. Moreover, in 2015, the overweight population will be 50% to 57% in China.
Obesity is a health problem around the world, and the causes of obesity are complex with multiple factors involved. More and more evidences show that obesity is not only a simple self-control problem, but also involves appetite regulation and energy metabolism. Obesity not only increases mortality and causes huge medical burden to mankind, but also affects life quality. Though the cause of obesity is not completely established, it is believed to be related to genetics, metabolism, biochemistry, culture and psychological factors. Accordingly, many causes of death are considered to be correlated with obesity including cancers, cardiovascular diseases, diabetes, chronic lower respiratory diseases, chronic hepatic disease and liver cirrhosis, hypertensive diseases, renal disease, etc., all of which make obesity a global issue. Recently, the prevalence of obesity is rising accompanied by the metabolic abnormality in blood pressure, blood sugar, insulin resistance, and dyslipidemia, which gradually leads to the incidence of diabetes, cardiovascular diseases, atherosclerosis, cerebrovascular disease, stroke, myocardial infarction, and eventually death.
The mechanisms of current drugs for losing weight can be divided into two categories, one is appetite suppression, and the other is blocking the intestinal absorption of dietary fat; wherein the main mechanism of marketed weight loss drugs is appetite suppression, the drugs comprising Sibutramine (Reductil®), Lorcaserin (Belviq®), Qsymia®, Contrave, etc, which have severe side effects and high risk of cardiovascular diseases. Take off-shelve weight loss drug Sibutramine (Reductil®) for example, once having a market share as high as 70 percent, Sibutramine (Reductil®) is to dually increase the satiety effect through the central nervous system and the metabolic rate in the periphery to achieve the weight loss effect. Sibutramine (Reductil®) is a noradrenaline and serotonin reuptake inhibitor which increases satiety to suppress appetite and therefore achieves the purpose of weight loss, wherein satiety increase is through the inhibiting of serotonin and noradrenaline reuptake via α1-adrenoceptors, β1-adrenoceptors and 5-HT2 receptor subtypes. Sibutramine (Reductil®) may cause high blood pressure and increase heart rate and was proved to increase cardiovascular risks in recent years, therefore, the drugs containing Sibutramine (Reductil®) ingredients were recalled from the markets of Europe, the United States, Australia, Taiwan and other countries in 2010.
Orlistat (Xenical®) blocks the intestinal dietary fat absorption and is the only legitimate weight loss drug for long-term use in most countries. It is a specific, reversible gastrointestinal lipolysis enzyme inhibitor in the stomach and small intestine. Orlistat (Xenical®) and lipase secreted from stomach and pancreas will form a covalent bond in the serine of the activation site of lipase to inactivate lipase activity as to inhibit the hydrolysis of triglyceride in dietary fat to absorbable free fatty acids and monoglycerides. Undigested triglycerides are unabsorbable and will be excreted directly. By means of inhibiting digestion enzymes secreted from pancreatic and intestine, the intestinal absorption of fat could be reduced up to 25% to 30%. Moreover, as the mechanism of Orlistat (Xenical®) is blocking fat absorption, some significant side effects were found including oil stool, increasing bowel movement, bloating related to gastrointestinal tract, interfering fat-soluble vitamin absorption, liver damage, gallstones, etc.
Massive demand and high profits of weight loss drugs have drawn pharmaceutical companies to researches and investment thereon. However, the safety of weight loss drugs is a challenging issue, especially severe side effects and the risk of cardiovascular disease. Therefore, the FDA had stopped approving weight loss drugs for years before 2012, causing inactivity of the pharmaceutical market. In 2012, FDA finally approved another four weight loss drugs, respectively Lorcaserin (Belviq®), Qsymia®, Contrave and Saxenda®, expected to bloom the market of weight loss drugs again.
The main ingredients of Qsymia® and Lorcaserin (Belviq®) are respectively phentermine-topiramate and lorcaserin, the main mechanism of them is increasing satiety and suppressing appetite to achieve weight loss purposes. Phentermine and topiramate are both old components of drug ingredients, wherein phentermine is a central sympathomimetics, and the mechanism of phentermine is suppressing appetite by stimulating adrenal gland to secret norepinephrine through hypothalamus; wherein the mechanism of topiramate is to promote the activity of the neurotransmitter GABA, blocking sodium channels, antagonizing glutamine receptor and inhibiting carbonic anhydrase to inhibit appetite and increase satiety. However, as early as in 1997, 24 cases of valvular heart disease were reported after taking weight loss drugs containing phentermine Fen-Phen (fenfluramine/dexfenfluramine-phentermine) drove FDA to recall fenfluramine and dexfenfluramine from the market. Phentermine is contraindicated for patients at high cardiovascular risk in many countries. Topiramate has been approved to treat epilepsy. The side effects of Phentermine-topiramate drug include tingling hands and feet, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Lorcaserin (Belviq®) is a 5-HT2C receptor activator, by activating hypothalamic pro-opiomelanocortin neurons (POMC neurons) to produce melanocyte stimulating hormone (α-MSH), and followed by inducing satiety, suppressing appetite and reducing dietary energy intake. Lorcaserin (Belviq®) is highly specific to 5-HT2C receptors instead of 5-HT2A and 5-HT2B receptors hence reduced the risk of severe cardiovascular diseases. As the side effects of Lorcaserin (Belviq®) include valve damage, headache, nausea, fatigue and urinary tract infections, FDA still requires the industry to conduct follow-up clinical monitoring, medication should be ceased if no significant weight loss after three months of Lorcaserin (Belviq®) treatment.
Contrave® is a dopamine and norepinephrine reuptake inhibitor, acting on the central nervous system to suppress appetite. The side effects of Contrave® are suicidal tendency, nausea, constipation, headache, vomiting, and dizziness. Saxenda® is a weight-loss drug administered by subcutaneous injection, and the main mechanism of Saxenda is mainly by reducing the rate of gastric emptying and increasing satiety to achieve the purpose of weight loss; the side effects are nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, loss of appetite and etc. Overall, the risk of cardiovascular disease and the safety of long-term use of new weight loss drugs remained to be monitored for longer period. Because of numerous side effects and safety concerns, these new weight loss drugs are not suitable for patients with cardiovascular diseases, especially Qsymia® which contains phentermine and reported to cause severe cardiovascular diseases made Qsymia® still forbidden in Taiwan and many other countries.
The main concern of weight loss drugs is the cardiovascular risk or mental safety such as dizziness, insomnia, palpitations, constipation and other side effects for long-term use. As the currently approved weight loss drugs have severe side effects, poor tolerance, and cardiovascular risk, the pharmaceutical market of weight loss drugs has not grown in pace with the global obese population and demand. Five among ten approved anti-obesity drugs from 1957 to 2014 which act through the mechanism involving appetite inhibition were recalled by FDA for their CVD risks or psychiatric safety concern included Sibutramine (trade name Reductil®) which launched in 2002 and shared 70% market revenue.
To overcome the described side effects and safety concern found in the launched weight loss products, better drugs developed based on weight loss function and reduction of CVD risk factors are urgently required.